EN 15842:2019
(Main)Foodstuffs - Detection of food allergens - General considerations and validation of methods
Foodstuffs - Detection of food allergens - General considerations and validation of methods
This document specifies how to use the standards for immunoassays, nucleic based and chromatographic methods and their relationship in the analysis of food allergens; and contains general definitions, requirements and guidelines for laboratory set-up, method validation requirements, description of methods, and test reports.
This document also specifies general guidelines for the requirements and use of reference materials for the determination of allergenic commodities in food products. The term "reference materials" in this document includes certified reference materials as well as quality control materials. Currently only a limited number of reference materials for food allergen determination are available. As new materials become accepted and validated, they can be appended as an annex to this document.
This document does not deal with sampling issues. It simply details processes involved from receipt of the laboratory sample to the end result.
Lebensmittel - Nachweis von Lebensmittelallergenen - Allgemeine Betrachtungen und Validierung von Verfahren
Dieses Dokument legt fest, wie die Normen zu Immunotests, auf Nukleinsäuren basierenden und chromatographischen Verfahren anzuwenden sind, und gibt deren Beziehung bei der Analyse von Lebensmittelallergenen an; es enthält allgemeine Definitionen, Anforderungen an und Leitlinien für den Aufbau von Laboratorien, Anforderungen an die Verfahrensvalidierung, Beschreibung der Verfahren und Untersuchungsberichte.
Dieses Dokument legt außerdem die allgemeinen Leitlinien für die Anforderungen und die Verwendung von Referenzmaterialien zur Bestimmung von allergenen Stoffen in Lebensmittelerzeugnissen fest. Der Begriff Referenzmaterial umfasst in diesem Dokument sowohl zertifizierte Referenzmaterialien als auch Qualitätskontrollmaterialien. Derzeit steht nur eine begrenzte Anzahl von Referenzmaterialien für die Bestimmung von Lebensmittelallergenen zur Verfügung. Wenn neue Materialien anerkannt und validiert worden sind, können sie als Anhang zu diesem Dokument hinzugefügt werden.
Das vorliegende Dokument beschäftigt sich nicht mit den Fragen der Probenahme. Es befasst sich lediglich im Einzelnen mit den vom Empfang der Laborprobe bis zum Endergebnis erforderlichen Prozessen.
Produits alimentaires - Détection des allergènes alimentaires - Considérations générales et validation des méthodes
Le présent document explique comment utiliser les étalons des méthodes basées sur les immunoessais, des méthodes chromatographiques et des méthodes basées sur l’acide nucléique, ainsi que leur relation dans l’analyse des allergènes alimentaires. Il contient également les définitions générales, les exigences et les lignes directrices relatives aux éléments suivants : l’installation du laboratoire, les exigences en matière de validation de la méthode, la description des méthodes et les rapports d’essai.
Le présent document spécifie également des lignes directrices générales relatives aux exigences et à l’utilisation des matériaux de référence pour doser les produits allergènes dans les produits alimentaires. Le terme « matériaux de référence » tel qu’il est utilisé ici englobe les matériaux de référence certifiés ainsi que les matériaux de contrôle de qualité. À ce jour il n’existe qu’un nombre limité de matériaux de référence pour doser les allergènes alimentaires. Dès que de nouveaux matériaux sont acceptés et validés, ils peuvent être ajoutés sous forme d’annexes au présent document.
Le présent document ne traite pas des questions d’échantillonnage. Il détaille simplement les processus en jeu, de la réception de l’échantillon pour laboratoire au résultat final.
Živila - Odkrivanje prisotnosti alergenov v živilih - Splošne ugotovitve in validacija metod
Ta dokument določa, kako uporabiti standarde za imunološke teste, nukleinske in kromatografske metode ter njihovo razmerje pri analizi prehranskih alergenov; vsebuje splošne opredelitve, zahteve in smernice za laboratorijsko pripravo, zahteve za validacijo metod, opis metod ter poročila o preskusih.
Ta dokument določa tudi splošne smernice za zahteve in uporabo referenčnih sestavin za določanje alergenih proizvodov v živilih. Izraz »referenčne sestavine« v tem dokumentu vključuje certificirane referenčne sestavine in sestavine za nadzor kakovosti. Trenutno je na voljo le omejeno število referenčnih sestavin za določanje alergenov v živilih. Ko bodo sprejete in potrjene nove sestavine, jih bo mogoče priložiti kot dodatek k temu dokumentu.
Ta dokument ne obravnava vprašanj vzorčenja. Opisuje zgolj postopke od prejema laboratorijskega vzorca do končnega rezultata.
General Information
Relations
Overview
EN 15842:2019 - published by CEN - provides general considerations and validation guidance for the detection of food allergens in foodstuffs. The standard describes how to use and relate immunoassays, nucleic acid‑based methods and chromatographic methods (for example ELISA, PCR and LC‑MS type techniques) for allergen analysis. It covers definitions, laboratory set‑up, method validation requirements, method descriptions and requirements for test reports. The document addresses the use of reference materials (certified and quality control materials) and clarifies that it does not cover sampling procedures.
Key Topics and Requirements
- Method scope and relationship: Guidance on combining or selecting immunoassay, nucleic acid and chromatographic approaches for reliable allergen detection.
- Method performance characteristics: Definitions and expectations for fitness for purpose, sensitivity, specificity, selectivity, linearity, applicability range, LOD/LOQ, recovery, precision, trueness and accuracy.
- Precision descriptors: Clear terms for repeatability and reproducibility (including limits and standard deviations) as applied to collaborative studies and validation.
- Validation and collaborative studies: Use of interlaboratory trials to demonstrate method performance and applicability.
- Laboratory organization and procedure: Recommendations on laboratory set‑up and handling from receipt of laboratory sample to reporting results (sampling itself is excluded).
- Reference materials: General guidelines on the use and requirements of reference materials (certified reference materials and QC materials); the standard anticipates annexation of new validated materials as they become available.
- Reporting and accreditation: Test reports should comply with EN ISO/IEC 17025 requirements.
Applications
- Validation and verification of laboratory methods for detecting allergenic commodities in processed and raw food products.
- Selection of the appropriate analytical workflow (screening vs confirmatory) for routine food safety testing and regulatory compliance.
- Quality control planning using reference materials and method performance monitoring in commercial and public laboratories.
- Supporting method development, interlaboratory comparisons and accreditation activities.
Who should use this standard
- Food testing laboratories and method developers
- Quality assurance and regulatory compliance teams in food industry
- Accreditation bodies and laboratory assessors
- Public health and food safety authorities
Related Standards
- EN 15633‑1 (immunological methods - general considerations)
- EN 15634‑1 (molecular biological methods - general considerations)
- EN ISO/IEC 17025 (test report and laboratory accreditation requirements)
Keywords: EN 15842:2019, food allergens, method validation, immunoassay, PCR, LC‑MS, reference materials, LOD, LOQ, repeatability, reproducibility, EN ISO/IEC 17025.
Frequently Asked Questions
EN 15842:2019 is a standard published by the European Committee for Standardization (CEN). Its full title is "Foodstuffs - Detection of food allergens - General considerations and validation of methods". This standard covers: This document specifies how to use the standards for immunoassays, nucleic based and chromatographic methods and their relationship in the analysis of food allergens; and contains general definitions, requirements and guidelines for laboratory set-up, method validation requirements, description of methods, and test reports. This document also specifies general guidelines for the requirements and use of reference materials for the determination of allergenic commodities in food products. The term "reference materials" in this document includes certified reference materials as well as quality control materials. Currently only a limited number of reference materials for food allergen determination are available. As new materials become accepted and validated, they can be appended as an annex to this document. This document does not deal with sampling issues. It simply details processes involved from receipt of the laboratory sample to the end result.
This document specifies how to use the standards for immunoassays, nucleic based and chromatographic methods and their relationship in the analysis of food allergens; and contains general definitions, requirements and guidelines for laboratory set-up, method validation requirements, description of methods, and test reports. This document also specifies general guidelines for the requirements and use of reference materials for the determination of allergenic commodities in food products. The term "reference materials" in this document includes certified reference materials as well as quality control materials. Currently only a limited number of reference materials for food allergen determination are available. As new materials become accepted and validated, they can be appended as an annex to this document. This document does not deal with sampling issues. It simply details processes involved from receipt of the laboratory sample to the end result.
EN 15842:2019 is classified under the following ICS (International Classification for Standards) categories: 67.050 - General methods of tests and analysis for food products. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 15842:2019 has the following relationships with other standards: It is inter standard links to EN 15842:2010. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 15842:2019 is associated with the following European legislation: EU Directives/Regulations: 882/2004. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
You can purchase EN 15842:2019 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2019
Nadomešča:
SIST EN 15842:2010
Živila - Odkrivanje prisotnosti alergenov v živilih - Splošne ugotovitve in validacija
metod
Foodstuffs - Detection of food allergens - General considerations and validation of
methods
Lebensmittel - Nachweis von Lebensmittelallergenen - Allgemeine Betrachtungen und
Verfahrensvalidierung
Produits alimentaires - Détection des allergènes alimentaires - Considérations générales
et validation des méthodes
Ta slovenski standard je istoveten z: EN 15842:2019
ICS:
67.050 Splošne preskusne in General methods of tests and
analizne metode za živilske analysis for food products
proizvode
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN 15842
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2019
EUROPÄISCHE NORM
ICS 67.050 Supersedes EN 15842:2010
English Version
Foodstuffs - Detection of food allergens - General
considerations and validation of methods
Produits alimentaires - Détection des allergènes Lebensmittel - Nachweis von Lebensmittelallergenen -
alimentaires - Considérations générales et validation Allgemeine Betrachtungen und Verfahrensvalidierung
des méthodes
This European Standard was approved by CEN on 12 August 2019.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 15842:2019 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 General aspects for methods and reference materials in food allergen analysis . 13
5 Guidance to the user for selection of methods . 14
6 Laboratory organization . 15
7 Procedure. 15
8 Interpretation and expression of the results . 16
9 Test report . 17
Bibliography . 18
European foreword
This document (EN 15842:2019) has been prepared by Technical Committee CEN/TC 275 “Food
Analysis - Horizontal Methods”, the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by April 2020, and conflicting national standards shall be
withdrawn at the latest by April 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 15842:2010.
Significant technical changes between this standard and EN 15842:2010 are as follows:
a) documents under normative references removed (2);
b) updated terms and definitions (3);
c) general considerations for methods and reference materials added (4.1);
d) requirements regarding the production and storage of reference materials deleted (4.3);
e) clause on "Quality assurance requirements" deleted;
f) the test report should comply with EN ISO/IEC 17025;
g) updated bibliography.
According to the CEN-CENELEC Internal Regulations, the national standards organisations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Introduction
The main focus of this document is on immunoassays, chromatographic and nucleic acid based methods
for the determination of food allergens. However, because of the rapid developments in this area, other
technologies can be considered.
The analysis of food allergens is performed by means of the following successive (or simultaneous)
steps. After sample collection, proteins, nucleic acids or other markers are extracted from the test
portion. Extracted analytes can be further purified, simultaneously or after the extraction process.
Afterwards, they are diluted (if necessary) and subjected to analytical procedures such as
immunoassays (e.g. ELISA), nucleic acid based assays (e.g. PCR) or chromatographic (e.g. LC-MS).
These steps are detailed in this document and in the following documents:
EN 15633-1, Foodstuffs — Detection of food allergens by immunological methods — Part 1: General
considerations
EN 15634-1, Foodstuffs — Detection of food allergens by molecular biological methods — Part 1: General
considerations
For the use of this document the term:
— ‘shall’ indicates a requirement;
— ‘should’ indicates a recommendation;
— ‘may’ indicates a permission; and
— ‘can’ indicates a possibility and/or a capability.
1 Scope
This document specifies how to use the standards for immunoassays, nucleic based and
chromatographic methods and their relationship in the analysis of food allergens; and contains general
definitions, requirements and guidelines for laboratory set-up, method validation requirements,
description of methods, and test reports.
This document also specifies general guidelines for the requirements and use of reference materials for
the determination of allergenic commodities in food products. The term “reference materials” in this
document includes certified reference materials as well as quality control materials. Currently only a
limited number of reference materials for food allergen determination are available. As new materials
become accepted and validated, they can be appended as an annex to this document.
This document does not deal with sampling issues. It simply details processes involved from receipt of
the laboratory sample to the end result.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http://www.electropedia.org/
— ISO Online browsing platform: available at https://www.iso.org/obp
3.1 Method performance characteristics
3.1.1
fitness for purpose
degree to which data produced by a measurement process enables a user to make technically and
administratively correct decisions for a stated purpose
Note 1 to entry: The measurement process can be based on a screening method, a confirmatory method or a
reference method.
Note 2 to entry: For further information refer to [10].
3.1.2
screening method
method that will rapidly and reliably eliminate (screen) a large number of negative (or positive) test
samples and restrict the number of test samples requiring the application of a rigorous method
Note 1 to entry: See [11].
3.1.3
practicability
ease of operations, in terms of sample throughput and costs, to achieve the required performance
criteria and thereby meet the specified purpose
[SOURCE: EN ISO 24276:2006+A1:2013, 3.1.22]
3.1.4
selectivity
extent to which a method can determine particular analyte(s) in mixtures or matrices without
interferences from other components
Note 1 to entry: See [12].
3.1.5
sensitivity
change in the response divided by the corresponding change in the concentration of a standard
(calibration) curve
Note 1 to entry: See [12].
3.1.6
specificity
property of a method to respond exclusively to the characteristic or analyte under investigation
Note 1 to entry: See [12].
3.1.7
linearity
ability to elicit test results that are directly, or by means of well defined, mathematical transformations,
proportional to the concentration of analyte in samples within a given range
Note 1 to entry: For further information refer to [12].
3.1.8
applicability range
interval of quantity values within which the analytical procedure has been demonstrated by
collaborative trial or other appropriate validation to have a suitable level of precision and accuracy
3.1.9
limit of detection
LOD
minimum amount or concentration of the analyte in test sample which can be detected reliably but not
necessarily quantified, as demonstrated by a collaborative trial or other appropriate validation
3.1.10
limit of quantitation
limit of determination
LOQ
lowest concentration or amount of the analyte in a test sample which can be quantitatively determined
with an acceptable level of precision and accuracy, as demonstrated by collaborative trial or other
appropriate validation
Note 1 to entry: For further information refer to [13].
3.1.11
precision
closeness of agreement between independent test/measurement results obtained under stipulated
conditions
Note 1 to entry: Precision depends only on the distribution of random errors and does not relate to the true
value or the specified value.
Note 2 to entry: The measure of precision is usually expressed in terms of imprecision and computed as
standard deviation of the test results or measurements results. Less precision is reflected by a larger standard
deviation.
Note 3 to entry: Quantitative measures of precision depend critically on the stipulated conditions. Repeatability
conditions and reproducibility conditions are particular sets of extreme stipulated conditions.
[SOURCE: ISO 3534-2:2006, 3.3.4]
3.1.12 Repeatability related terms
3.1.12.1
repeatability
precision under repeatability conditions
Note 1 to entry: Repeatability can be expressed quantitatively in terms of the dispersion characteristics of the
results.
[SOURCE: ISO 3534-2:2006, 3.3.5]
3.1.12.2
repeatability conditions
observation conditions where independent test/measurement results are obtained with the same
method on identical test/measurement items in the same test or measuring facility by the same
operator using the same equipment within short intervals of time
Note 1 to entry: Repeatability conditions include:
— the same measurement procedure or test procedure;
— the same operator;
— the same measuring or test equipment used under the same conditions;
— the same location;
— repetition over a short period of time.
[SOURCE: ISO 3534-2:2006, 3.3.6]
3.1.12.3
repeatability limit
r
repeatability critical difference for a specified probability of 95 %
[SOURCE: ISO 3534-2:2006, 3.3.9]
3.1.12.4
repeatability standard deviation
standard deviation of test results or measurement results obtained under repeatability conditions
Note 1 to entry: It is a measure of the dispersion of the distribution of test or measurement results under
repeatability conditions.
Note 2 to entry: Similarly “repeatability variance” and “repeatability coefficient of variation” can be defined and
used as measures of the dispersion of test or measurement results under repeatability conditions.
[SOURCE: ISO 3534-2:2006, 3.3.7]
3.1.13
collaborative study
interlaboratory study in which each laboratory uses a defined method of analysis to analyse identical
portions of homogenous material to assess the performance characteristics obtained for the method of
analysis
Note 1 to entry: Guidelines for performing collaborative trials are elaborated in ISO 5725-1 [3] and in IUPAC
harmonized protocol 1995 [14].
3.1.14 Reproducibility related terms
3.1.14.1
reproducibility
precision under reproducibility conditions
Note 1 to entry: Reproducibility can be expressed quantitatively in terms of the dispersion characteristics of the
results.
Note 2 to entry: Results are usually understood to be corrected results.
[SOURCE: ISO 3534-2:2006, 3.3.10]
3.1.14.2
reproducibility conditions
observation conditions where independent test/measurement results are obtained with the same
method on identical test/measurement items in different test or measurement facilities by different
operators using different equipment
[SOURCE: ISO 3534-2:2006, 3.3.11]
3.1.14.3
reproducibility limit
R
reproducibility critical difference for a specified probability of 95 %
[SOURCE: ISO 3534-2:2006, 3.3.14]
3.1.14.4
reproducibility standard deviation
standard deviation of test results or measurement results obtained under reproducibility conditions
Note 1 to entry: It is a measure of the dispersion of the distribution of test or measurement results under
reproducibility conditions.
Note 2 to entry: Similarly, “reproducibility variance” and “reproducibility coefficient of variation” can be
defined and used as measures of the dispersion of test or measurement results under reproducibility conditions.
[SOURCE: ISO 3534-2:2006, 3.3.12]
3.1.15
recovery
proportion of the amount of analyte, present in or added to the analytical portion of the test material,
which is extracted and determined for measurement
Note 1 to entry: See [15].
3.1.16
metrological traceability
property of a measurement result whereby the result can be related to a reference through a
documented unbroken chain of calibrations, each contributing to the measurement uncertainty
[SOURCE: JCGM 200:2012, 2.41, modified — notes were removed]
3.1.17
trueness
closeness of agreement between the expectation of a test result or a measurement result and a true
value
Note 1 to entry: The measurement of trueness is usually expressed in terms of bias.
Note 2 to entry: Trueness is sometimes referred to as “accuracy of the mean”. This usage is not recommended.
Note 3 to entry: In practice, the accepted reference value is substituted for the true value.
[SOURCE: ISO 3534-2:2006, 3.3.3]
3.1.18
accuracy
closeness of agreement between a test result or measurement result and the true value
Note 1 to entry: In practice, the accepted reference value is substituted for the true value.
Note 2 to entry: The term “accuracy”, when applied to a set of test or measurement results, involves a
combination of random components and a common systematic error or a bias component.
Note 3 to entry: Accuracy refers to a combination of trueness and precision.
[SOURCE: ISO 3534-2:2006, 3.3.1]
3.1.19
bias
difference between the expectation of a test result or measurement result and a true value
Note 1 to entry: Bias is the total systematic error as contrasted to random error. There could be one or more
systematic error components contributing to the bias. A larger systematic difference from the true value is
reflected by a larger bias value.
Note 2 to entry: The bias of a measuring instrument is normally estimated by averaging the error of indication
over an appropriate number of repeated measurements. The error of indication is the: “indication of a measuring
instrument minus a true value of the corresponding input quantity”.
[SOURCE: ISO 3534-2:2006, 3.3.2, modified — note 3 was removed]
3.1.20
robustness
ruggedness
measure of the capacity of an analytical procedure to remain unaffected by small variations in method
parameters and provides an indication of the method’s reliability during normal usage
[SOURCE: ISO 16577:2016, 3.184]
3.2 Sample and material related terms
3.2.1
matrix
components of the sample other than the analyte of interest
Note 1 to entry: Each matrix has generally a common name that permits classification.
3.2.2
laboratory sample
sample as prepared for sending to the laboratory and intended for inspection or testing
[SOURCE: ISO 78-2:1999, 3.1]
3.2.3
test sample
sample prepared from the laboratory sample and from which test portions will be taken
[SOURCE: ISO 78-2:1999, 3.2]
3.2.4
test portion
the quantity of material drawn from the test sample (or from the laboratory sample if both are the
same) and on which the test or observation is actually carried out
[SOURCE: ISO 78-2:1999, 3.3]
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기사 제목: EN 15842:2019 - 식품 - 식품 알레르기 원료의 탐지 - 일반적인 고려사항 및 방법의 검증 기사 내용: 이 문서는 식품 알레르기의 분석에 있어서 면역검사, 핵산기반 및 크로마토그래픽 방법의 표준을 사용하는 방법을 명시하며, 일반적인 정의, 요구사항, 연구실 구성에 대한 지침, 방법 검증 요구사항, 방법의 설명 및 검사 보고서를 포함합니다. 이 문서는 또한 식품 제품 내 알레르기성 제품을 결정하기 위한 참조 재료의 요구사항과 사용에 대한 일반적인 지침을 명시합니다. 이 문서에서 "참조 재료"라는 용어는 인증된 참조 재료 및 품질 관리 재료를 포함합니다. 현재 식품 알레르기 검출을 위한 참조 재료는 제한적으로 사용되고 있습니다. 새로운 재료가 인정되고 유효성이 검증되면 이 문서의 부록으로 첨부될 수 있습니다. 이 문서는 샘플링 문제에 대해 다루지 않습니다. 단지 연구실 샘플을 수령에서 최종 결과물까지의 과정을 상세히 설명하고 있습니다.
The article discusses the standard EN 15842:2019, which provides guidelines for the detection of food allergens. It covers various methods such as immunoassays, nucleic-based, and chromatographic methods, and explains their relationship in the analysis of food allergens. The document includes definitions, requirements, and guidelines for laboratory set-up, method validation, description of methods, and test reports. It also provides guidelines for the use of reference materials in determining allergenic commodities in food products. The document does not address sampling issues but focuses on the processes involved from receiving the laboratory sample to obtaining the final result.
기사 제목: EN 15842:2019 - 식품 - 식품 알레르기원 감지 - 일반적인 고려 사항 및 방법의 검증 기사 내용: 이 문서는 식품 알레르기원을 분석하기 위해 면역측정법, 핵산 기반 및 색채법의 표준을 사용하는 방법을 명시하며, 일반적인 정의, 요구사항 및 시험실 구축을 위한 지침, 방법의 검증 요구사항, 방법 설명 및 테스트 보고서를 담고 있습니다. 또한, 이 문서는 식품 제품에서 알레르기성 상품을 확인하기 위한 참조 물질의 요구사항과 사용에 대한 일반적인 지침을 명시합니다. 이 문서에서 "참조 물질"은 인증 된 참조 물질뿐만 아니라 품질 관리 물질도 포함됩니다. 현재 식품 알레르기 원자 정량을 위한 참조 물질은 제한적으로만 사용 가능합니다. 새로운 물질이 수락되고 검증되면, 이 문서의 부록으로 추가될 수 있습니다. 이 문서는 샘플링 문제에 대해서는 다루지 않으며, 단지 실험실 샘플 수령부터 최종 결과물까지의 과정을 상세히 설명합니다.
記事タイトル：EN 15842:2019 - 食品 - 食品アレルゲンの検出 - 一般的な考慮事項と方法の検証 記事内容：この文書は、食品アレルゲンの分析において、免疫測定法、核酸ベースの方法、クロマトグラフィー法の標準の使用方法を指定し、一般的な定義、要件、およびラボの設置に関する指針、方法の検証要件、方法の説明、およびテストレポートを含んでいます。 また、食品製品におけるアレルゲン性商品の決定に関する参照物質の要件と使用の一般的なガイドラインも指定しています。この文書では「参照物質」とは認定された参照物質だけでなく、品質管理物質も含まれます。現在、食品アレルゲンの定量に使用するための参照物質は限られていますが、新しい物質が受け入れられ、検証された場合、この文書の付録として追加することができます。 この文書では、サンプリングの問題には触れておらず、ただ実験室のサンプルの受け取りから最終結果までの過程を詳細に説明しています。
The article discusses the standards and methods for detecting food allergens. It provides guidelines for using immunoassays, nucleic based, and chromatographic methods, and explains their relationship in analyzing food allergens. The document also includes definitions, requirements, and guidelines for setting up a laboratory, validating methods, describing methods, and reporting test results. It also addresses the use of reference materials for determining allergenic commodities in food products. However, it does not cover sampling issues, focusing instead on the processes involved in analyzing laboratory samples.
記事タイトル：EN 15842:2019 - 食品 - 食品アレルゲンの検出 - 一般的な考慮事項と方法の検証 記事内容：この文書は、食品アレルゲンの検出における免疫測定、核酸ベース、クロマトグラフィー法などの標準の使用方法について具体化し、一般的な定義、要件、実験室の設置に関するガイドライン、方法の検証要件、方法の説明、およびテスト報告書を含んでいます。 また、食品製品中のアレルゲン性原料の決定における基準物質の要件と使用の一般的なガイドラインも指定しています。この文書では、認定された基準物質および品質管理物質を含めた基準物質という用語を使用しています。現在、食品アレルゲンの決定のための基準物質は限られていますが、新しい物質が受け入れられ、検証された場合、この文書への追記として追加されることができます。 この文書はサンプリングの問題には触れていません。単に実験室でのサンプルの受け取りから最終結果までのプロセスについて詳細に説明しています。
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